Availability of the 2023 Universal registration document

• 6 Aeson® artificial hearts marketed to date
• Enrollment of the first cohort of 3 patients in the EFS[1] in the USA finalized
• Cash position of €58 million at June 30, 2021, covering the Company’s activities through to mid-2022
• Videoconference with Stéphane Piat today at 5 pm Paris time

Paris, September 15, 2021 – 7:00 am CEST

CARMAT (FR0010907956, ALCAR), the designer and developer of the world’s most advanced total artificial heart, aiming to provide a therapeutic alternative to people suffering from end-stage biventricular heart failure, today reports its results for the first half of the year to June 30, 2021[2] and issues an update on its latest progress and main strategic objectives.

Stéphane Piat, Chief Executive Officer of CARMAT, commented: “Following the granting of CE marking in December 2020, CARMAT dedicated most of its resources to preparing the commercial launch in Europe, initiating the EFS in the US and strengthening its supply chain. Despite the constraints associated with the COVID-19 pandemic, CARMAT achieved key milestones: since July, 6 patients in leading German and Italian hospitals did benefit from Aeson®, the world’s first physiological artificial heart, in a commercial setting. CARMAT also successfully completed the enrollment of the first cohort of 3 patients in the EFS study, with some of the largest and renowned American cardiology centers such as Duke University Hospital, paving the way to the evaluation of our device in the US, the world’s largest medical device market. The very positive feedback regarding the implantations of Aeson® in both commercial and clinical trials settings is further demonstrating our confidence that our device represents a valid alternative to heart transplants. We anticipate that around a dozen European centers, primarily in Germany, will be commercially active by the end of 2021. In order to support this momentum, CARMAT has also been working on ramping up its production activities, which should allow the company to manufacture Aeson® prostheses at an increasing pace in order to appropriately supply hospitals that would like to offer our unique technology to their patients”.

[1] Early Feasibility Study

[2] First-half results were approved by the Board on September 13, 2021 and have been the subject of a limited review by the statutory auditors. The 2021 half-year financial report was published today and is available on the Company’s website.

Paris, September 3, 2021 – 7:00 am CEST

CARMAT (FR0010907956, ALCAR), the designer and developer of the world’s most advanced total artificial heart, aiming to fulfill an unmet medical need by providing a therapeutic alternative to people suffering from end-stage biventricular heart failure, today announces the appointment of Ivo Simundic as Sales director for the DACH region (Germany, Austria and Switzerland).

Graduated from University of Applied Sciences in Ulm in Mechanical Engineering and holding an MBA in Corporate Management, Ivo Simundic is a seasoned sales director with over 20 years of experience in the medical device industry.

Ivo started his career within the healthcare sector in 1999 at Medtronic as a Sales Engineer in Cardiac Rhythm Management for South-West Germany, before moving to the position of Area Sales manager for Automated External Defibrillators for the entire German market in 2007. From 2007 to 2011, he held several management positions at Philips Respironics (Sales Director Respiratory Drug Delivery for Central and Eastern Europe and Russia) and Emcools Emergency Medical Cooling Systems (Director sales EMEA).

In 2011, Ivo Simundic joined Xenios AG where he co-invented, co-developed and obtained the CE marking for the i-cor® project – the first synchronized pulsatile cardiac assist for interventional cardiology to treat cardiogenic shock and to protect cath-lab interventions. Following the acquisition of Xenios AG by Fresenius Medical Care in 2016, he became the Company’s Head of Heart Therapies (Cardiology and Cardiac Surgery). Prior to joining CARMAT, he held the position of Head of i-cor® Therapies at Xenios AG / Fresenius Medical Care.

Ivo Simundic, Sales director for DACH region at CARMAT, stated: “I am delighted to join the CARMAT team at this crucial stage of its development and to contribute to the acceleration of the company’s growth in the DACH markets which I know very well as I was responsible for the commercialization of many highly invasive and complex therapeutic and rescue systems. I have always worked with innovative devices, and I am honored to be able to contribute to bringing a system as innovative as Aeson® to patients in hospitals in Germany but also in Austria and Switzerland.”

Stéphane Piat, Chief Executive Officer of CARMAT, concluded: “We are pleased to welcome Ivo to our team. His deep commercial and medical expertise represents a major asset for the execution of our business strategy in Germany, but also going forward in Austria and Switzerland. Together with our medical and technical teams, he will drive Aeson®’s adoption and sales in this strategic region.”

Paris, August 27, 2021 – 7:00 am CEST

CARMAT (FR0010907956, ALCAR), the designer and developer of the world’s most advanced total artificial heart, aiming to provide a therapeutic alternative for people suffering from end-stage biventricular heart failure, today announces the third implant of its Aeson® bioprosthetic artificial heart in a commercial setting.

This new commercial implant of the Aeson® device was performed by Prof. Assad Haneya and his team of the Department of Cardiovascular Surgery at University Medical Center Schleswig-Holstein (UKSH) in Kiel (Director: Prof. Jochen Cremer). With 14,000 employees in over 85 clinics and institutes, UKSH is one of the largest medical care centers in Europe and the first training provider in Schleswig-Holstein. UKSH in Kiel is recognized as one of Germany’s leading heart centers with a history of thoracic transplantation for several decades. It provides maximum medical care in this federal state and guarantees medical-technical care at the highest level, especially for patients who require highly differentiated diagnosis and therapy.

Prof. Assad Haneya, Director of the Transplantation and Mechanical Circulatory Support Program at UKSH, declared: “We are pleased to have successfully implanted the CARMAT TAH in our center last week. The patient who received the device suffered from severe end-stage biventricular heart failure and he was eligible to an urgent heart transplant. During the last weeks, we noticed a further deterioration with signs of a beginning multi-organ failure and the use of Aeson® was a natural choice.”

Dr. Bernd Panholzer, Director of Cardiovascular Intensive Care Unit, added: “A few days after the procedure, the device is providing all the necessary support and the patient is recovering well. Since the device has some key characteristics similar to a real heart, such as pulsatility, hemo-compatibility and self regulation, we expect to meet the needs of many other patients placed on the waiting lists with this new type of therapy.”

Stéphane Piat, Chief Executive Officer of CARMAT, concluded: “We are proud that University Medical Center Schleswig-Holstein, one of the largest in Germany and even in Europe in terms of the use of mechanical circulatory support, has chosen Aeson® as a treatment option for this critically ill patient. I would like to thank Prof. Assad Haneya and his teams for their trust and our technical staff for the support during the entire process. We are experiencing growing interest in our therapy and are pursuing its commercial deployment in Europe as planned.”

The implant was performed at UofL Health – Jewish Hospital by University of Louisville physicians within the framework of the U.S. Early Feasibility Study

Paris, August 25, 2021 – 7:00 am CEST

CARMAT (FR0010907956, ALCAR), the designer and developer of the world’s most advanced total artificial heart, aiming to fulfill an unmet medical need by providing a therapeutic alternative to people suffering from end-stage biventricular heart failure, announces the second center implanting its bioprosthetic artificial heart, Aeson®, in the United States within the framework of the Early Feasibility Study (EFS).

The implant procedure was performed by a team led by Dr. Mark S. Slaughter, Professor and Chair of the Department of Cardiovascular and Thoracic Surgery at the University of Louisville and UofL Physician at Jewish Hospital, Louisville, Kentucky. UofL Health and the University of Louisville are known for ground-breaking cardiovascular innovation research, especially in circulatory support technologies. Jewish Hospital is the second U.S. hospital to implant Aeson® within the framework of the EFS. Three additional U.S. centers are fully trained and are currently screening patients for the study.

In accordance with the study protocol approved by the FDA, 10 transplant-eligible patients are expected to be enrolled in this trial. The primary study endpoint is patient survival at 180 days post-implant or a successful cardiac transplantation within 180 days post-implant. It is a staged study with a progress report of the first 3 patients after 60 days, before the enrollment of the next 7 patients.

Mark S. Slaughter, MD, heart surgeon at UofL Health – Jewish Hospital and University of Louisville, and principal investigator of the study, stated: “We are pleased to be part of the first U.S. centers to investigate this new artificial heart technology. This clinical study will help us determine whether the device’s distinguishing features such as hemocompatibility and blood flow autoregulation are beneficial to critically ill patients suffering from biventricular heart failure who currently have very limited treatment options.”

Stéphane Piat, Chief Executive Officer of CARMAT, concluded: “We are honored that our device is implanted at UofL Health – Jewish Hospital and University of Louisville, which is recognized throughout the United States for its quality of care and cardiovascular research. I would like to congratulate the teams at the hospital, as well as our technical and medical staff, on this exceptional milestone for both patients and our company.”

The implant was performed at Hannover Medical School

Paris, July 26, 2021 – 6:00 pm CEST

CARMAT (FR0010907956, ALCAR), the designer and developer of the world’s most advanced total artificial heart, aiming to provide a therapeutic alternative for people suffering from end-stage biventricular heart failure, today announces the first implant of its Aeson® bioprosthetic artificial heart in Germany.

This new implant of the Aeson® artificial heart was performed by Prof. Jan D. Schmitto and his interdisciplinary Heart Team of the Department of Cardiothoracic and Transplant Surgery (Director: Prof. Axel Haverich) at Hannover Medical School (Medizinische Hochschule Hannover – MHH), in Germany. The MHH Hospital is a maximum care hospital with a nationwide catchment area, recognized for its quality research in several domains such as transplantation and regenerative medicine, infection and immunology, biomedical engineering and implants.              

Prof. Jan D. Schmitto, Director of the Mechanical Circulatory Support and Cardiac Transplantation Program at Hannover Medical School, declared: “The implant of the first CARMAT TAH in Germany represents another milestone in the field of Mechanical Circulatory Support Devices. The extremely ill patient suffered from long-lasting congenital heart disease and was finally fulminantly decompensated. He was treated by extracorporeal membrane oxygenation (ECMO) therapy for many days before he received a left ventricular assist device (LVAD) plus aortic valve replacement (AVR) and a temporary right ventricular assist device (RVAD) a week ago. Based on persistent right heart failure which made the RVAD not able to be weaned, there were no other treatment options left than Aeson® in this specific situation. Therefore, we asked the CARMAT team to join our forces for this ultima ratio use in order to face that critical situation of our patient. Unfortunately, because of its terminally ill status and the extremely fragile clinical profile, the patient passed away in the postoperative course. However, we observed that Aeson® has been able to directly intraoperatively stabilize the hemodynamic situation of the patient and has also been able to cope with the high pulmonary arterial pressures. Overall, we have been impressed by the promising performance of the device and we are looking forward to include it in our portfolio to save many lives in the future.”

Stéphane Piat, Chief Executive Officer of CARMAT, concluded: “We supported Prof. Schmitto’s team in Hannover last Friday for the treatment of a young patient suffering from end-stage biventricular heart failure due to Congenital Heart Disease. Because of the lack of treatment options for this severe heart failing patient and taking into account the challenging management of his severe Pulmonary Arterial Hypertension (PAH), Aeson® has been identified as the last possible solution. Despite challenging hemodynamic conditions, our device was able to deal with this very high level of PAH. This finding could open new opportunities in terms of indication of use for congenital heart diseases. We continue screening patients in Hannover as well as in other centers in Germany which have already been trained in the use of Aeson®.”